# FDA recall Z-1101-2025

> **Nobel Biocare** · Class II · device recall initiated 2025-01-10.

## Product

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

## Reason for recall

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

## Distribution

U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.

## Key facts

- **Recall number:** Z-1101-2025
- **Recalling firm:** Nobel Biocare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-10
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goteborg, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2025

## Citation

> AI Analytics. FDA recall Z-1101-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1101-2025. Source: US FDA. Licensed CC0.

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